HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM

HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM is an FDA 510(k)-cleared medical device (K960287) manufactured by Nidek, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 1996. Regulation: 8.